VenUS II: larval therapy Venous Ulcer Study

ISRCTN ISRCTN55114812
DOI https://doi.org/10.1186/ISRCTN55114812
Protocol serial number HTA 01/41/04
Sponsor University of York (UK)
Funder NIHR Health Technology Assessment Programme - HTA (UK)
Submission date
18/06/2004
Registration date
18/06/2004
Last edited
08/02/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Nicky Cullum
Scientific

Dept of Health Sciences
SRB (Area 2)
University of York
Heslington
York
YO10 5DD
United Kingdom

+44 (0)1904 321343
nac2@york.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymVenUS II
Study objectivesNon-healing leg ulcers are common, costly to the NHS and distressing for patients. Many leg ulcers contain slough and necrotic tissue and, whilst removal of these tissues (debridement) is widely thought to contribute to healing, direct evidence is lacking. Larval therapy has been proposed as a quick and effective debridement strategy and is increasingly used in the NHS, mainly by nurses. Larval therapy may achieve debridement more swiftly than modern wound dressings, which promote a moist environment aiding self debridement, and, unlike surgical debridement, larval therapy use is not reliant on highly trained personnel or the fitness of the patient for surgery. A further benefit of larval therapy, namely the removal of wound bacteria and Methicillin-Resistant Staphylococcus Aureas (MRSA) in particular, has been suggested, but robust evidence of this is also required. This study will establish the cost-effectiveness of larval therapy in the healing of venous and mixed arterial/venous leg ulcers; it will also assess the impact of larval therapy on wound microbiology, including MRSA, and the acceptability of the treatment for patients.

Please note that, as of 16 January 2008, the anticipated end date of this trial has been updated from 30 June 2007 to 30 April 2008.
Ethics approval(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedVenous and mixed aetiology leg ulcers
Intervention3 armed trial: Larval therapy (loose and bagged) and Purilon hydrogel
Intervention typeOther
Primary outcome measure(s)

Added 10/07/08:
Time to healing of reference ulcer

Key secondary outcome measure(s)

Added 10/07/08:
1. Time to debridement of reference ulcer
2. Health related quality of life
3. Bacterial load (including MRSA)
4. Adverse event data
5. Costs of leg ulcer treatments

Completion date30/04/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration370
Key inclusion criteriaAdults over 18 years old with leg uclers containing slough and/or necrotic tissue
Key exclusion criteriaDoes not comply with inclusion criteria
Date of first enrolment01/09/2003
Date of final enrolment30/04/2008

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Dept of Health Sciences
York
YO10 5DD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article cost-effectiveness results 19/03/2009 Yes No
Results article results 19/03/2009 Yes No
Other publications HTA report 01/11/2009 Yes No
Study website Study website 11/11/2025 11/11/2025 No Yes
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